Examination of Adverse Reactions After COVID-19 Vaccination Among Patients With a History of Multisystem Inflammatory Syndrome in Children
Authors: Matthew D. Elias, Dongngan T. Truong, Matthew E. Oster, Felicia L. Trachtenberg, Xiangyu Mu, Pei-Ni Jone, Elizabeth C. Mitchell, Kirsten B. Dummer, S. Kristen Sexson Tejtel, Onyekachukwu Osakwe, Deepika Thacker, Jennifer A. Su, Tamara T. Bradford, Kristin M. Burns, M. Jay Campbell, Thomas J. Connors, Laura D’Addese, Daniel Forsha, Olivia H. Frosch, Therese M. Giglia, Lauren R. Goodell, Stephanie S. Handler, Keren Hasbani, Camden Hebson, Anita Krishnan, Sean M. Lang, Brian W. McCrindle, Kimberly E. McHugh, Lerraughn M. Morgan, R. Mark Payne, Arash Sabati, Eyal Sagiv, Yamuna Sanil, Faridis Serrano, Jane W. Newburger, Audrey Dionne, Gail Pearson, Victoria Pemberton, D’Andrea Egerson, Lynn Mahony, Julie Miller, Kerri Hayes, Allison Crosby-Thompson, Ayesha Amarnath, James Ambrosoli, Cassandra Artis, Kay Rubio, Chitra Kinhikar, Amanda Marshall, Devine Mbiydzenyuy, Valentina Kazlova, Chenwei Hu, Lozan Eyob, Beverly Slayton, Lauren DiStefano, Jami Honig, Tiffany Bowie, Rob Nero, Emily Birmingham, Robin Rowe, Melissa Joyce, Cole Gallagher, Djenawa Bowman, Mo Zhang, Alissa Mooney, Andreea Dragulescu, Christopher Lam, Rae Yeung, Beth Gamulka, Jessica Bainton, Martha Rolland, Patti Walter, Simran Mahanta, Thomas Giorgio, Numaira Khan, Annette Baker, Lisa Jean Buckley, Jessica Jones, LaTina Watson, Anna Clarke, Tor-Samuel-Aleer Leek, Gwendolyn Orav, Tonia Morrison, Katherine Lupton, Donna Sylvester, Dana Albizem, Kristin Lanzilotta, Grace Marks, Madison Johnson, Megan Bickford, Linda Lambert, Lilly Fagatele, Andrea Curless, Mark Russell, Tammy Doman, Marisa Almaguer, Lauryn Dugan, Kathleen Rathge, Elizabeth Seibert, Mary Stumpf, Jennifer Howell, Jyoti Patel, Gloria Mitscher, Melissa Burnett, Kolby Sanders-Lewis, Brooke Evans, William T. Mahle, Lazaros Kochilas, Madison Rudow, Susie Gentry, Kristie Le, Caitlen Taylor, Lara Shekerdemian, Elias Moussi, Sandra Pena, Ricardo Pignatelli, Olukayode Garuba, Asela Liu, Brett Anderson, Chantal Sanchez, Karen Martyrosyan, Jacqueline R. Szmuszkovicz, Andrew L. Cheng, Sindhu Mohandas, Jodie K. Votava-Smith, Shuo Wang, Pierre C. Wong, Kavita Sharma, Maria Martinez, Parvin Mohazabnia, Wendy Rojas, Joseph Block, Regina Cole, Jennifer Maldonado, Shubhika Srivastava, Carol Prospero, Varsha Zadokar, Ed Williams, Michael Carr, Kathleen Van't Hof, Colleen Sullivan, Michael A. Portman, Hidemi Kajimoto, Deepthi G. Nair, Mikayla A. Beckley, Joan Pancheri, Katheryn Crane, Ashraf Harahsheh, Charles Berul, Laura Olivieri, Mitchell Haverty, Alix Fetch, Christina Schott, Sarah Litt, Jennifer Nelson, Michelle Hite, Isabel Glassmeyer, Todd Nowlen, Ashley Herzberg, Samantha Stack, Jade Porche, Susan Park, Amy Johnson, Divya Shakti, Aimee S. Parnell, Michael D. Weiland, Phenique Parker, Jeffrey A. Kertis, Charlotte V. Hobbs, Candace M. Howard, Shivraj Savadkar, Aren E. Worrell, Madelyn R. Barr, Heather Williams, David Gordy, Preeti Vemula, Zachary White, Jemylle Grace S. Morato, Sandra Tyler, Krissie Hock, Michelle Sykes, Carl Owada, Mayra Lemus Rangel, Isaura Macias, Gautham Singh, Sanjeev Aggarwal, Charmaine Williams-Farr, Nancy Sullivan, Aiman Almasnaah, Vishnu Undyala, Brian Hannah, Mary McCall, Jacob Strelow, Rachel Downey, Ken Shaffer, Chesney Castleberry, Lisa Pomeroy, Rachel Amsellem, Olga Shamailova, Marla Johnston, Juan Carlos Muniz, Moya Chang, Ryan Shea, Miriam Davis, Maryanne Chrisant, Danielle Katz, Norma Barton, Doris Alaby, Paulette Smith, Kevin Friedman, Francesca Sperotto, Ed Marcus, Raquel Ferreira, Patrick McGeoghegan, Michael Taylor, Joshua Germann, Andrew Powell, Andrew Mackie, Jogarao Gobburu, Sally Hunsberger, Patrick McQuillen, Michael Spaeder, Dianne Atkins, Craig Broberg, David J. Driscoll, Frank Evans, Sally A. Hunsberger, Liza-Marie Johnson, Thomas J. Knight, Paul Lipkin, J. Philip Saul
Journal: JAMA Network Open (2023)

Importance Data are limited regarding adverse reactions after COVID-19 vaccination in patients with a history of multisystem inflammatory syndrome in children (MIS-C). The lack of vaccine safety data in this unique population may cause hesitancy and concern for many families and health care professionals. Objective To describe adverse reactions following COVID-19 vaccination in patients with a history of MIS-C. Design, Setting, and Participants In this multicenter cross-sectional study including 22 North American centers participating in a National Heart, Lung, and Blood Institute, National Institutes of Health–sponsored study, Long-Term Outcomes After the Multisystem Inflammatory Syndrome in Children (MUSIC), patients with a prior diagnosis of MIS-C who were eligible for COVID-19 vaccination (age ≥5 years; ≥90 days after MIS-C diagnosis) were surveyed between December 13, 2021, and February 18, 2022, regarding COVID-19 vaccination status and adverse reactions. Exposures COVID-19 vaccination after MIS-C diagnosis. Main Outcomes and Measures The main outcome was adverse reactions following COVID-19 vaccination. Comparisons were made using the Wilcoxon rank sum test for continuous variables and the χ 2 or Fisher exact test for categorical variables. Results Of 385 vaccine-eligible patients who were surveyed, 185 (48.1%) received at least 1 vaccine dose; 136 of the vaccinated patients (73.5%) were male, and the median age was 12.2 years (IQR, 9.5-14.7 years). Among vaccinated patients, 1 (0.5%) identified as American Indian/Alaska Native, non-Hispanic; 9 (4.9%) as Asian, non-Hispanic; 45 (24.3%) as Black, non-Hispanic; 59 (31.9%) as Hispanic or Latino; 53 (28.6%) as White, non-Hispanic; 2 (1.1%) as multiracial, non-Hispanic; and 2 (1.1%) as other, non-Hispanic; 14 (7.6%) had unknown or undeclared race and ethnicity. The median time from MIS-C diagnosis to first vaccine dose was 9.0 months (IQR, 5.1-11.9 months); 31 patients (16.8%) received 1 dose, 142 (76.8%) received 2 doses, and 12 (6.5%) received 3 doses. Almost all patients received the BNT162b2 vaccine (347 of 351 vaccine doses [98.9%]). Minor adverse reactions were observed in 90 patients (48.6%) and were most often arm soreness (62 patients [33.5%]) and/or fatigue (32 [17.3%]). In 32 patients (17.3%), adverse reactions were treated with medications, most commonly acetaminophen (21 patients [11.4%]) or ibuprofen (11 [5.9%]). Four patients (2.2%) sought medical evaluation, but none required testing or hospitalization. There were no patients with any serious adverse events, including myocarditis or recurrence of MIS-C. Conclusions and Relevance In this cross-sectional study of patients with a history of MIS-C, no serious adverse events were reported after COVID-19 vaccination. These findings suggest that the safety profile of COVID-19 vaccination administered at least 90 days following MIS-C diagnosis appears to be similar to that in the general population.